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U.S. Department of Health and Human Services

Class 2 Device Recall DRX Revolution Mobile Xray System

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 Class 2 Recall
DRX Revolution Mobile Xray System
see related information
Date Posted November 01, 2013
Recall Status1 Open
Recall Number Z-0132-2014
Recall Event ID 65586
Premarket Notification
510(K) Number
K120062 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
Code Information Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013
Recalling Firm/
Manufacturer
Carestream Health Inc.
150 Verona St
Rochester, New York 14608-1733
Manufacturer Reason
for Recall
Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.
Quantity in Commerce 331 units
Distribution Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = CARESTREAM HEALTH, INC.
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